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Antiretroviral Therapy in Infants: Earlier Is Better

Improved long-term suppression of HIV is associated with antiretroviral therapy started by age 3 months.

The best time to start antiretroviral therapy is as controversial in HIV-infected children as it is in adults. In infants, CD4-cell counts and HIV RNA levels are unreliable predictors of disease progression. Although the risk of rapid HIV disease progression may justify an aggressive approach to therapy, little is known about the long-term safety and effectiveness of combination antiretroviral therapy started at birth. A recent NIH- and industry-sponsored trial among HIV-infected young children in the U.S. provides insight into this dilemma. The 52 participants were sequentially assigned to one of three treatment regimens; they were also stratified by whether therapy was started early (3 months of age) or delayed (>3 months).

At week 16, 62% of children had HIV RNA levels <1000 copies/mL, with little difference among the three regimens. At weeks 48 and 200, levels <400 copies/mL were seen in 50% and 44% percent of children, respectively. The combination nelfinavir/nevirapine/stavudine/lamivudine was associated with significantly higher viral suppression rates than were the other regimens, both of which comprised nonnucleoside and nucleoside reverse-transcriptase inhibitors. Significantly more early-therapy than delayed-therapy infants had HIV RNA levels <400 copies/mL at 200 weeks. Drug-resistance testing did not guide therapy, and most infants with drug resistance at baseline had worse outcomes.

Comment: HIV-infected infants beginning a four-drug regimen at age 3 months showed viral suppression for up to 4 years. Although definitive conclusions from this trial are limited by the nonrandomized study design, the findings support the use and additional evaluation of early treatment strategies, as well as drug-resistance testing to guide therapy.

— Diane V. Havlir, MD

Published in Journal Watch Infectious Diseases June 28, 2004

Citation(s):

Luzuriaga K et al. A trial of three antiretroviral regimens in HIV-1-infected children. N Engl J Med 2004 Jun 10; 350:2471-80.

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